Device product
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
Z-1027-2022
Product summary
- Firm
- restor3d Inc.
- Event
- Event 89983
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4 units
- Official record key
device-enforcement:Z-1027-2022
Official wording
Reason: During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
Code information: Model: 6101-20181018; Lot: 2022010031; UDI: 00840097501574
Distribution pattern: US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
Derived failure modes
-
Unknown
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.